NCT06420167RecruitingPhase 2
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design. Participants will be: * screened for the trial via an online platform * contacted by study personal to obtain electronic consent * enrolled in the trial if eligible and consented * contacted by study personal for further instructions and directions * sent dapagliflozin oral medication (supplied by the site pharmacy) * followed up regularly with the study team via telemedicine or other online avenues * monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months * continue treatment for 6 months
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 May 2024
- Start date
- 11 Jul 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Diseases
- Amyloidosis
- NCT number
- NCT06420167
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 11 Jul 2024 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for \<6 months prior to enrollment.
- Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding.
- Current or previous use of any SGLT2i.
- Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) \<3 months prior to enrollment.
Other illness
- Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past.
- Known allergic reactions to components of the dapagliflozin.
- Treatment requiring type 1 or type 2 diabetes mellitus.
- Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy)
- Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers).
Lab values
- Baseline eGFR \<25 mL/min/1.73m2.
Who the study is looking for
- Provision of signed and dated informed consent form.
- Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile/web applications for study purposes.
- Age ≥18 years.
- Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of \>1.0 g/day proteinuria without any other identifiable cause.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician.
- Residence in the state of Michigan.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.